EXCimEr Laser for Long lENgTh Lesions in Below-The-Knee Arteries Study

NCT00718991 | Terminated Phase 2

• 1 other identifier: FMRP-005
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

This investigation is designed to assess the immediate and long-term angiographic patency outcomes of excimer laser recanalisation followed by PTA in the treatment of long (\>50 mm) infrapopliteal lesions in patients with critical limb ischemia (CLI) The Spectranetics Turbo elite™ excimer laser catheters are percutaneous intravascular devices constructed of multiple optical fibers around a guidewire lumen. The laser catheters transmit ultraviolet energy from the Spectranetics CVX-300® Excimer Laser System to the obstruction in the artery. The ultraviolet energy is delivered to the tip of the laser catheter to photo-ablate fibrous, calcific and atheromatous lesions, thus recanalizing diseased vessels.

Conditions

Peripheral Arterial Occlusive Disease

Keywords

CLI; excimer laser; debulking

Outcome Measures

Primary Outcomes (2)

• Angiographic patency for laser + PTA, as defined by < 50% stenosis in the target lesion with straight line flow to the foot

  12 months

• Absence of Major Adverse Events defined as death, amputation of treated limb and target vessel revascularization

  6 months

Secondary Outcomes (6)

• Immediate angiographic laser recanalization success + PTA, defined as a residual diameter stenosis ≤30% and absence of flow-limiting dissection on visual assessment after combined excimer laser and PTA recanalization treatment

  Procedure

• Absence of Major Adverse Events defined as death, amputation of treated limb and target vessel revascularization

  12 months

• Limb-salvage rate at all follow-up visits, defined as lack of major amputation of treated limb. Limb-salvage rate (LSR) is defined as 1 minus major amputation rate

  12 months

• Serious adverse events defined as being fatal, life-threatening, or judged to be severe by the investigator; result in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged or new hospitalization

  12 months

• Clinical success at follow-up is defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification

  12 months

Study Arms (1)

1

EXPERIMENTAL

CLI patients receiving excimer laser recanalisation for the treatment of long infrapopliteal lesions

Device: Spectranetics Turbo elite™ excimer laser catheter

Interventions

Spectranetics Turbo elite™ excimer laser catheter DEVICE

The Spectranetics Turbo elite™ excimer laser catheters are percutaneous intravascular devices constructed of multiple optical fibers around a guidewire lumen. The laser catheters transmit ultraviolet energy from the Spectranetics CVX-300® Excimer Laser System to the obstruction in the artery. The ultraviolet energy is delivered to the tip of the laser catheter to photo-ablate fibrous, calcific and atheromatous lesions, thus recanalizing diseased vessels.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The treatment vessel is DeNovo
• Stenotic (\>50%) or occlusive atherosclerotic disease of infrapopliteal artery(s)
• Length of target lesion is \> 50 mm
• Reference target vessel diameter between 2-4.0 mm by visual assessment
• Documented Rutherford Class 4 or 5 symptomatic critical limb ischemia
• The patient must be \>18 years of age
• Life-expectancy of more than 12 months
• The patient has no child bearing potential or negative serum pregnancy test within 7 days of the index procedure
• The patient must be willing and able to return to the appropriate follow-up times for the duration of the study
• The patient must provide written patient informed consent that is approved by the ethics committee
• All inflow lesions successfully (\<30 residual stenosis) treated prior to target lesion treatment during same procedure or according standard of care without unresolved complications
• At least one angiographically visible target at the ankle for establishment of straight line flow.

You may not qualify if:

• Patient refusing treatment
• The target vessel segment diameter is not suitable for available catheter design.
• Unsuccessfully treated endovascular or bypass( \>30% residual stenosis) proximal ( iliac, SFA, popliteal) inflow limiting arterial/graft stenosis
• Lesion lies within or adjacent to an aneurysm
• The patient has a known allergy to heparin, Aspirin or other antiaggregant therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies.
• The patient has a history of prior life-threatening contrast media reaction.
• The patient is currently enrolled in another investigational device or drug trial.
• The patient is currently breast-feeding, pregnant or intends to become pregnant.
• The patient is unable to provide informed consent
• The patient has end stage renal disease (currently on any form of dialysis)
• Known Left Ventricular Ejection Fraction \< 35%
• The patient has had an MI within 30 days prior to enrollment
• The patient has had a CVA within 90 days prior to enrollment
• Serum Creatinine \> 150 µmol
• The patient has a previous bypass in the target limb

Sponsors & Collaborators

• Flanders Medical Research Program: lead
• Spectranetics Corporation: collaborator

Study Sites (2)

Imelda Hospital

Bonheiden, 2820, Belgium

Location

AZ St-Blasius

Dendermonde, 9200, Belgium

Location

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1

Study Officials

• Patrick Peeters, MD

  Imelda Hospital, Bonheiden, Belgium

  PRINCIPAL INVESTIGATOR

• Marc Bosiers, MD

  AZ St-Blasius, Dendermonde, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2008
• First Posted: July 21, 2008
• Study Start: July 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: March 9, 2015

Record last verified: 2015-03

Locations

BE (2)